Cleared Traditional

K942470 - PROTECTAIDE PERSONAL PROTECTION PACK NO...

K942470 is the FDA 510(k) clearance for PROTECTAIDE PERSONAL PROTECTION PACK NO... by Protectaide, Inc.. It is a Class 2 General Hospital device (product code FXX) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K942470 · Protectaide, Inc. · General Hospital
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Oct 1994
Decision
146d
Days
Class 2
Risk

K942470 is an FDA 510(k) clearance for the PROTECTAIDE PERSONAL PROTECTION PACK NO. 08315. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Protectaide, Inc. (Rockwall, US). The FDA issued a Cleared decision on October 18, 1994 after a review of 146 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Protectaide, Inc. devices

Submission Details

510(k) Number K942470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1994
Decision Date October 18, 1994
Days to Decision 146 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 129d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FXX Mask, Surgical

All 409
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